Emerging use cases of blockchain in healthcare and the life sciences – PMLiVE
Interest in the digital currency Bitcoin has propelled the concept of the ‘blockchain’ to the forefront of current discussions around cryptocurrencies. As the fundamental technology behind Bitcoin, the blockchain has traditionally been associated with the financial services sector. However, this incredibly flexible distributed ledger technology (DLT) has many more use cases than just financial transactions and it has now become a buzzword across all commercial sectors.
A recent report published by PreScouter, a Chicago-based research intelligence company, reviews three broad areas of blockchain deployment within the life sciences sector, including applications in drug development, supply chain management, clinical trials management and patient-centric usage. The report also reviews use cases of blockchain within this sector, from proof-of-concept to real-world, large-scale deployments and identifies early adopters of blockchain, including key collaborations, across the pharmaceutical, biotechnology and healthcare industries.
What is the blockchain?
The blockchain is a decentralised, real-time list of records, which are called ‘blocks’. Each block contains an immutable timestamp that cannot be retroactively modified, as well as a cryptographic label of both the previous and next block in the chain, called a ‘hash’, which provides provenance. This ability to authenticate the history of the previous block allows traceability to the original transaction, which is known as the ‘genesis block’. Finally, each block contains the actual data of a record, which could be a financial transaction, a multiparty contract, a drug’s batch record, etc. The blockchain architecture prevents surreptitious modification of data or its provenance. Blockchains are managed by peer-to-peer networks of nodes, thus providing privacy and storage redundancy within a democratic, decentralised system.
Drug development and supply chain management
Two key concepts in drug manufacturing and supply chain management are provenance (the origin and/or ownership of an entity such as a drug, which attests to its authenticity or quality) and tracking/tracing (an unbroken chain of records of each step that a product such as a drug undergoes in its life cycle, from the raw materials used in manufacture to the ultimate sale by a pharmacy). Current processes that permit drug provenance and supply chain tracking are fragmented due to data silos, which can lead to human errors and fraud such as drug counterfeiting.
Blockchain provides a mechanism to ensure quality across all steps of drug development and distribution, ranging from immutable batch records of active pharmaceutical ingredients (APIs) in the manufacturing process to easily reporting adverse events and recalling drug batches. One significant example of blockchain implementation in this area is the public-private partnership between the US Food and Drug Administration (FDA) and IBM. This collaboration is using blockchain to identify, track and trace prescription medicines and vaccines distributed throughout the country. Another example is the MediLedger Project, which brings together a consortium of drug manufacturers and distributors to track or trace drug batches and improve drug supply chain management using internet-of-things (IoT) principles built upon the backbone of the blockchain.
Clinical trials management
Clinical trials are highly complex endeavours, with a range of stakeholders including patients or study subjects, study sponsors, drug and medical device providers, clinical investigators, healthcare professionals and government regulatory bodies. On the one hand, sensitive data such as patients’ health records and the trial’s outcomes must remain private and secure, and the trial protocol itself must be immutable and transparent. On the other hand, the entire process must be conducted in a transparent manner for all stakeholders, to ensure that protocols are strictly followed. Moreover, secure but efficient communication between stakeholders from different professions and multiple clinical trial sites is necessary.
Due to this unique set of challenges, clinical trials are a perfect test case for the blockchain technology, as it provides for immutability, scalability, and traceability of records with multiple data access permission levels. For example, deployment of a clinical trial on a blockchain could help manage patient consent, maintain trial protocols, track patient samples and ensure secure communications between trial sites.
One such recent example came in 2019, where Boehringer Ingelheim agreed to manage its clinical trials on blockchain technology provided by IBM Canada. And in a collaboration between Triall and Sphereon, applications to improve auditability and operational efficiency in clinical trials is in development, with the Verial clinical document management solution now being used in the first clinical trial in production on a blockchain.
There are a number of potential impacts of blockchain technology focused on the patient within healthcare. One early use case shows how ‘smart contracts’ (self-executing contracts built on the blockchain) allow for seamless and secure management of patient consent and health record ownership across data silos. Additional implementations can be found within prescription medicine management, patient claims and billings management, and data security for wearables and other IoT medical devices, as well as deployment in personalised medicine.
Numerous examples already exist of patient-centric blockchain usage. Guardtime, in collaboration with healthcare regulatory agencies in Estonia and the United Kingdom, is working on tracking and managing patients’ consent for the use of their healthcare records. The Prescrypt project, spearheaded by Deloitte in the Netherlands, is pursuing a completely different focus by working to put patients’ drug prescriptions on the blockchain for secure communication, usage tracking and analysis by healthcare professionals.
The use cases highlighted in PreScouter’s report demonstrate the power of blockchain in all sectors of the healthcare space. Adoption of blockchain within the life sciences has admittedly been slower than in other sectors, as the potential use cases of blockchain are not as straightforward and the rapidly evolving landscape of players presents a challenge for companies seeking to adopt the technology. Despite this slow adoption to date, it is predicted that blockchain technology will add values in excess of USD $3bn by 2025 in the life sciences sector.
Clear use cases are emerging within the healthcare, biopharmaceutical and medical technology industries, where the blockchain will have a major impact by providing robustness, efficiency and transparency. According to Dr Rakesh Joshi, PreScouter researcher and co-author of the report: “As the technology matures and early use cases emerge to help mitigate risks, more mainstream adoption is to be expected within the next five years, which will enable blockchain technology to bear its fruits in the life sciences ecosystem.”
Charles Wright is Technical Director, Healthcare & Life Sciences at PreScouter
11th May 2020
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